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Trial record 1 of 1 for:    NCT02411812 | Recruiting, Not yet recruiting Studies
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Effects of the Herbst Appliance With Different Anchorages and Twin-Block Appliance in Class II Malocclusion (HASA)

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ClinicalTrials.gov Identifier: NCT02411812
Recruitment Status : Recruiting
First Posted : April 8, 2015
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Klaus Barretto-Lopes, Rio de Janeiro State University

Brief Summary:
The purpose of this study is to determine if the Herbst appliance with indirect skeletal anchorage in mini-implants is capable of preventing excessive inclination of the lower incisors at the end of the treatment when compared to the Herbst appliance with dental anchorage and Twin-Block appliances in patients with Class II malocclusion and overjet ≥ 6 mm.

Condition or disease Intervention/treatment Phase
Malocclusion, Angle Class II Device: Herbst appliance with skeletal anchorage Device: Herbst appliance with dental anchorage Device: Twin-Block appliance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of the Herbst Appliance With Skeletal Anchorage or Dental Anchorage, and Twin-Block Appliance in Class II Malocclusion: A Randomized Clinical Trial
Actual Study Start Date : August 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Herbst appliance with skeletal anchorage
Group treated with the Herbst appliance with indirect skeletal anchorage in mini-implants.
Device: Herbst appliance with skeletal anchorage
Group treated with the Herbst appliance with indirect skeletal anchorage in mini-implants.

Active Comparator: Herbst appliance with dental anchorage
Group treated with the conventional Herbst appliance with dental anchorage.
Device: Herbst appliance with dental anchorage
Group treated with the conventional Herbst appliance with dental anchorage.

Active Comparator: Twin-Block appliances
Group treated with Twin-Block appliance.
Device: Twin-Block appliance
Group treated with Twin-Block appliance




Primary Outcome Measures :
  1. Lower incisors position changes as measured by tomographic superimposition of the mandible. [ Time Frame: 12 months ]
    Comparison in lower incisors position between the two groups at the end of the treatment.


Secondary Outcome Measures :
  1. Morphological mandible changes as measured by tomographic superimposition of the cranial base. [ Time Frame: 12 months ]
    Comparison between the changes of the mandible in the two groups at the end of the treatment.

  2. Maxilla changes as measured by tomographic superimposition of the cranial base. [ Time Frame: 12 months ]
    Comparison between the changes of the maxilla in the two groups at the end of the treatment.

  3. Changes in relationship between maxilla and mandible as measured by tomographic superimposition of the cranial base. [ Time Frame: 12 months ]
    Comparison between the changes of the relationship between the maxilla and the mandible in the two groups at the end of the treatment.

  4. Lower molar position changes as measured by tomographic superimposition of the mandible. [ Time Frame: 12 months ]
    Comparison between the changes of the lower molar in the three groups at the end of the treatment.

  5. Upper molar position changes as measured by tomographic superimposition of the maxilla. [ Time Frame: 12 months ]
    Comparison between the changes of the upper molar in the three groups at the end of the treatment.

  6. Facial changes as measured by tomographic superimposition of the face [ Time Frame: 12 months ]
    Comparison between the facial changes in the three groups.



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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Teenagers aged from 10 to 14 years old (both genders)
  • Parental permission with a signed consent form
  • Referral from the Orthodontics Clinic of the State of Rio de Janeiro University or private clinics
  • Presenting Class II, Division 1 malocclusion with convex profile and minimum overjet of 6 mm in permanent dentition.

Exclusion Criteria:

  • Missing teeth.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411812


Contacts
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Contact: Klaus B Lopes, PhD 55-21-99148-4446 klausbarretto@uol.com.br
Contact: Nathália Palomares, MSc 55-21-98883-0124 palomares.nathalia@gmail.com

Locations
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Brazil
Rio de Janeiro State University Recruiting
Rio de Janeiro, Brazil, 20551-030
Contact: Klaus B Lopes, PhD    55-21-99148-4446    klausbarretto@uol.com.br   
Contact: José Augusto M Miguel, PhD    55-21-97282-1500    jamiguel66@gmail.com   
Principal Investigator: Klaus B Lopes, PhD         
Sub-Investigator: José Augusto M Miguel, PhD         
Sub-Investigator: Cátia C Quintão, PhD         
Principal Investigator: Tatiana A Lima, PhD         
Sub-Investigator: Nathalia Palomares, MSc         
Sponsors and Collaborators
Klaus Barretto-Lopes
Investigators
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Principal Investigator: Klaus B Lopes, PhD Rio de Janeiro State University
Study Director: Kevin D O'Brien, PhD University of Manchester
Study Chair: José Augusto M Miguel, PhD Rio de Janeiro State University
Study Director: Nathália Palomares, MSc Rio de Janeiro State University
Publications:

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Responsible Party: Klaus Barretto-Lopes, Instructor of Orthodontics, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT02411812    
Other Study ID Numbers: HASA
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Keywords provided by Klaus Barretto-Lopes, Rio de Janeiro State University:
Orthodontic Appliances, Functional
Herbst Appliance
Malocclusion, Angle Class II
Additional relevant MeSH terms:
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Malocclusion
Malocclusion, Angle Class II
Overbite
Tooth Diseases
Stomatognathic Diseases